20 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Infrared Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
AIM™SUPRACONDYLAR NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868005305·
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK112151·DD tempMED are pre-colored dental milling blank...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515025219·Lagenbeck Ret, x-tra deep, 15mm x 85mm
Foundation Surgical Interwedge
FDA UDI
FOUNDATION SURGICAL GROUP INC·00810141040250·Trial - 18x12x15
NUANCE
FDA 510(k)
FDA Class 2
·Dental
VOLUMINA
FDA 510(k)
FDA Class 2
·Radiology
HAMILTON-C1
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·August 30, 2024
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 8, 2020
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981330941·Lollipop Trial, Anterior-Angled, 18mm x 12mm x ...
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981441449·Lollipop Trial 18mm x 12mm x 55mm, 15°
1812-15 AIM SUPRACONDYLAR NAIL
FDA Adverse Event
Malfunction
·DEPUY ACE MEDICAL CO·Product code HSB·June 15, 1998
ENDURANT BIFURCATED STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 22, 2011
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·June 21, 2013
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·September 30, 2008
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·June 10, 2022
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018